CLINICAL TRIALS PROFILE FOR SIPULEUCEL-T
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All Clinical Trials for sipuleucel-t
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00901342 ↗ | Open Label Study of Sipuleucel-T | Completed | Dendreon | Phase 2 | 2009-08-01 | This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC). |
| NCT01338012 ↗ | Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer (CRPC) Patients Previously Treated on Dendreon Study P-11 (NCT00779402) | Completed | Dendreon | Phase 2 | 2011-11-01 | This study is being conducted to examine the immune response generated by sipuleucel-T in subjects previously treated with sipuleucel-T in the androgen dependent setting. The study will also assess the safety of receiving up to 3 additional infusions of sipuleucel-T. This is an open-label, uncontrolled, multicenter study, conducted in up to 14 clinical trial sites. The anticipated duration of the study is approximately 6 years. |
| NCT01420965 ↗ | Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer | Terminated | Augusta University | Phase 2 | 2012-09-01 | Background: - Sipuleucel-T is a new treatment for advanced stage prostate cancer. It takes cells from a person with prostate cancer and treats them in the laboratory. Then it returns the cells to the person to help the immune system fight the cancer. Sipuleucel-T may be combined with the drug CT-011 to boost its ability to kill cancer cells. The chemotherapy drug cyclophosphamide will also be given, either before or after the cells are collected at the start of the treatment. Objectives: - To test the effectiveness of Sipuleucel-T, CT-011, and cyclophosphamide for prostate cancer. Eligibility: - Men at least 18 years of age who have advanced prostate cancer. Design: - Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies. - This study has two parts, with different participants in each part. All participants will be monitored with frequent blood tests and imaging studies. - Part I: - Participants will provide cells for the Sipuleucel-T treatment three times. The first time will be 3 days before the chemotherapy. The second time will be 10 days after chemotherapy. The third time will be 24 days after chemotherapy. - Participants will have one dose of cyclophosphamide the day before the first dose of Sipuleucel-T. - Participants will have Sipuleucel-T about 3 days after each cell donation. - Part II: - Participants will be in three groups: Sipuleucel-T given alone, given with CT-011, or given with both cyclophosphamide and CT-011. - Participants will provide cells for the Sipuleucel-T treatment three times, as in Part I. - Participants will have Sipuleucel-T about 3 days after each cell donation, and will receive treatment with the other drugs as directed by the study doctors. |
| NCT01431391 ↗ | Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer | Completed | Dendreon | Phase 2 | 2011-09-01 | The main purpose of this study was to determine whether ADT started before or after sipuleucel-T led to a better immune system response. This study also evaluated the safety of sipuleucel-T and ADT treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific antigen (PSA) values over time. |
| NCT01487863 ↗ | Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer | Completed | Dendreon | Phase 2 | 2011-12-01 | The purpose of this study was to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on the ability to manufacture sipuleucel-T (by assessing sipuleucel-T product parameters), and to assess the safety and efficacy of sipuleucel-T with concurrent or sequential administration of abiraterone acetate plus prednisone in men with metastatic castrate resistant prostate cancer. |
| NCT01650350 ↗ | Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer | Terminated | Maria Constantinou | Phase 2 | 2012-11-01 | will scientifically evaluate whether Low Dose Naltrexone (LDN) has activity in refractory solid tumors within the context of a phase II clinical study |
| NCT01804465 ↗ | Sipuleucel-T With Immediate vs. Delayed Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Blockade for Prostate Cancer | Completed | Bristol-Myers Squibb | Phase 2 | 2014-04-22 | The purpose of this study is to find out what effects taking ipilimumab, as an immediate or delayed treatment, following completion of sipuleucel-T (SipT) treatment, has on patients and their prostate cancer. |
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